Apparatus and method for endovascular device guiding and positioning using physiological parameters

• US 8,597,193 B2
• Filed: 06/26/2008
• Issued: 12/03/2013
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Vasonova, Inc. (Teleflex Incorporated)
• Inventors: Grunwald, Sorin, Sander, Fiona Maria, Samson, Wilfred J., Hill, Bradley, Cheng, E. Tina
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): REARDON, ROCHELLE D
• Application Number:
  US12/147,401
• Publication Number:
  US 20090005675A1
• Time in Patent Office: 1,986 Days
• Field of Search: 600/437, 600/462, 600/466, 600/467, 600/472, 600/454, 600/468, 600/724
• US Class Current: 600/468
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/283 : Invasive
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 : Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/366 : Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/369 : Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 : Electromyography [EMG]
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 7/04 : Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61B 8/02 : Measuring pulse or heart rate
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/42 : Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 8/461 : Displaying means of special interest
• CPC Class Codes: A61B 8/463 : characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/465 : adapted to display user selection data, e.g. icons or menus
• CPC Class Codes: A61B 8/488 : involving Doppler signals
• CPC Class Codes: A61B 8/565 : involving data transmission via a network
• CPC Class Codes: G09B 23/288 : for artificial respiration or heart massage

Abstract

An endovascular access and guidance system has an elongate body with a proximal end and a distal end; a non-imaging ultrasound transducer on the elongate body configured to provide in vivo non-image based ultrasound information of the vasculature of the patient; an endovascular electrogram lead on the elongate body in a position that, when the elongate body is in the vasculature, the endovascular electrogram lead electrical sensing segment provides an in vivo electrogram signal of the patient; a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and an output device configured to display a result of information processed by the processor.

Claims

1. An endovascular device, comprising:

an elongate body with a proximal end and a distal end;

a non-imaging ultrasound transducer on the elongate body;

an endovascular electrogram lead on the elongate body in a position that, when the endovascular device is in the vasculature, the endovascular electrogram lead is in contact with blood;

a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and

a memory for storing instructions which, when executed by the processor, causes the processor to;

calculate one or more blood flow features extracted from the non-imaging ultrasound signal, wherein the one or more blood flow features includes a ratio of a blood flow velocity away from the ultrasound transducer and a blood flow velocity towards the ultrasound transducer;

calculate one or more electrogram features extracted from the electrogram signal, wherein the one or more electrogram features includes a P-wave amplitude; and

determine a position of the elongate body within the vasculature based on the calculated one or more blood flow features and one or more electrogram features.

2. The endovascular device of claim 1 wherein the endovascular electrogram lead is positioned at the elongate body distal end.

3. The endovascular device of claim 1 wherein the electrical sensing segment of an endovascular electrogram lead is positioned within 3 cm of the elongate body distal end.

4. The endovascular device of claim 1 wherein the electrical sensing segment of an endovascular electrogram lead is positioned within 3 cm of the non-imaging ultrasound transducer.

5. The endovascular device of claim 1 wherein the electrical sensing segment of an endovascular electrogram lead is positioned proximal to the non-imaging ultrasound transducer.

6. The endovascular device of claim 1 further comprising:

a second endovascular electrogram lead on the elongate body in a position that, when the endovascular device is in the vasculature, the second endovascular electrogram lead is in contact with blood.

7. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned about 5 cm from the endovascular electrogram lead.

8. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned about 5 cm from the elongate body distal end.

9. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned at a distance spaced apart from the endovascular electrogram lead so that the second endovascular electrogram lead detects a baseline electrogram signal when the endovascular electrogram lead is detecting a target electrogram signal.

10. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned at a distance related to the length of the superior vena cava such that when the endovascular electrogram lead is in the superior vena cava the second endovascular electrogram lead is outside of the superior vena cava.

11. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned such that when the electrical sensing segment of the endovascular electrogram lead is positioned to detect a targeted electrogram signal from the heart the electrical sensing segment of the second endovascular electrogram lead is positioned to detect a comparison baseline ECG signal.

12. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned such that when the electrical sensing segment of the endovascular electrogram lead is positioned to detect a targeted electrogram signal from the brain the electrical sensing segment of the second endovascular electrogram lead is positioned to detect a comparison baseline EEG signal.

13. The endovascular device of claim 6 wherein electrical sensing segment of the second endovascular electrogram lead is positioned such that when the electrical sensing segment of the endovascular electrogram lead is positioned to detect a targeted electrogram signal from a muscle the electrical sensing segment of the second endovascular electrogram lead is positioned to detect a comparison baseline EMG signal.

14. The endovascular device of claim 1 wherein the endovascular electrogram lead is moveable from a stowed condition within the elongate body and a deployed condition outside of the elongate body.

15. The endovascular device of claim 14 wherein the stowed endovascular electrogram lead curves the distal end of the endovascular device.

16. The endovascular device of claim 14 wherein when the endovascular electrogram lead is in the stowed condition the electrical sensing segment is positioned to detect an electrogram signal.

17. The endovascular device of claim 1 further comprising:

a steering element connected to the endovascular lead for directing the proximal end of the elongate body.

18. The endovascular device of claim 17 wherein the steering element provides torque to the elongate body distal end.

19. The endovascular device of claim 1 wherein the endovascular electrogram lead in use extends at least partially about the elongate body.

20. The endovascular device of claim 1 wherein the endovascular lead further comprises:

an atraumatic tip.

21. The endovascular device of claim 1 wherein the endovascular electrogram lead is formed from a shape memory alloy.

22. The endovascular device of claim 1 wherein the endovascular electrogram lead is adapted for use to move the ultrasound sensor away from a blood vessel wall.

23. The endovascular device of claim 1 wherein the endovascular device comprises a coated metal braided structure and a portion of the coating on the metal braided structure is removed and the exposed metal braided structure functions as an endovascular electrogram lead electrical sensing segment.

24. The endovascular device of claim 1 further comprising:

an atraumatic tip on the distal end of the endovascular device.

25. The endovascular device of claim 24 wherein the atraumatic tip comprises an ultrasound lens.

26. The endovascular device of claim 25 wherein the ultrasound lens is a divergent lens.

27. The endovascular device of claim 1 further comprising:

an opening in the elongate body; and

a lumen within the elongate body in communication with the opening and the elongate body proximal end.

28. The endovascular device of claim 1 further comprising an additional sensor on the endovascular device for measuring a physiological parameter.

29. The endovascular device of claim 28 wherein the additional sensor is an optical sensor.

30. The endovascular device of claim 29 wherein the physiological parameter is related to an optical property detected within the vasculature.

31. The endovascular device of claim 28 wherein the additional sensor is a pressure sensor.

32. The endovascular device of claim 31 wherein the physiological parameter is related to a pressure measurement obtained within the vasculature.

33. The endovascular device of claim 28 wherein the additional sensor is an acoustic sensor.

34. The endovascular device of claim 33 wherein the physiological parameter is related to an acoustic signal detected within the vasculature.

35. The endovascular device of claim 1 wherein the elongate body comprises a catheter.

36. The endovascular device of claim 1 wherein the elongate body comprises a guide wire.

37. The endovascular device of claim 1 wherein the elongate body comprises a stylet.

38. The endovascular device of claim 1 wherein the elongate body is adapted to deliver a therapy to the patient.

39. The endovascular device of claim 1 wherein the elongate body is adapted to provide endovascular access for another device.

40. The endovascular device of claim 1 wherein the processor is further configured to receive and process a signal from the non-imaging ultrasound transducer comprising a signal from at least one of the group consisting of:

a venous blood flow direction, a venous blood flow velocity, a venous blood flow signature pattern, a pressure signature pattern, A-mode information and a preferential non-random direction of flow and to receive and process a signal from the endovascular electrogram lead the signal comprising at least one of the group consisting of;

an electrocardiogram signal, a P-wave pattern, a QRS-complex pattern, a T-wave pattern, an EEG signal and an EMG signal.

41. The endovascular device of claim 1 wherein the processor is configured to process the signal from the non-imaging ultrasound transducer to determine a flow directed towards the ultrasound transducer and a flow directed away from the ultrasound transducer.

42. The endovascular device of claim 1 wherein the processor is configured to process the signal from the non-imaging ultrasound transducer to determine a venous blood flow signature pattern.

43. The endovascular device of claim 1 wherein the processor is configured to process only a portion of the signal from the non-imaging ultrasound transducer that corresponds to a selected electrogram trigger signal.

44. The endovascular device of claim 43 wherein the selected electrogram trigger signal is a portion of an ECG wave.

45. The endovascular device of claim 1 wherein the processor is configured to process the endovascular electrogram signal to determine peak to peak amplitude changes of an QRS complex in an electrocardiogram.

46. The endovascular device of claim 1 wherein the processor is configured to process the endovascular electrogram signal to determine peak to peak amplitude changes of an R-wave in an electrocardiogram.

47. The endovascular device of claim 1 wherein the processor is configured to process the endovascular electrogram signal to determine peak to peak amplitude changes of an P-wave in an electrocardiogram.

48. The endovascular device of claim 1 wherein the processor is configured to process the endovascular electrogram signal to compare the relative amplitude of an P-wave to the relative amplitude of another portion of an electrocardiogram.

49. The endovascular device of claim 1 wherein the processor is configured to process the ultrasound signal to determine a blood flow velocity profile and processing the endovascular electrogram signal to determine a shape of the intravascular electrocardiogram.

50. The endovascular device of claim 49 wherein the processor is configured to correlate the blood flow velocity profile and the shape of the intravascular electrocardiogram to determine the location of the endovascular device within the vasculature.

51. The endovascular device of claim 1, wherein the memory for storing instructions which, when executed by the processor, causes the processor to further determinine whether the elongate body has reached the superior vena cava based on the calculated one or more non-pulsatile blood flow features and one or more electrogram features.

52. An endovascular device, comprising:

an elongate body with a proximal end and a distal end;

a non-imaging ultrasound transducer on the elongate body;

an endovascular electrogram lead on the elongate body in a position that, when the endovascular device is in the vasculature, the endovascular electrogram lead is in contact with blood;

a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and

a memory for storing instructions which, when executed by the processor, causes the processor to;

calculate one or more blood flow features extracted from the non-imaging ultrasound signal, wherein the one or more blood flow features includes a ratio of a blood flow power spectrum away from the ultrasound transducer and a blood flow power spectrum towards the ultrasound transducer;

calculate one or more electrogram features extracted from the electrogram signal, wherein the one or more electrogram features includes a P-wave amplitude; and

determine a position of the elongate body within the vasculature based on the calculated one or more blood flow features and one or more electrogram features.